Microbiologist

Duties and Responsibilities

• Conducts routine environmental monitoring sampling and testing including viable air, viable surface, and non-viable particulate testing in non-sterile and aseptic processing environments
• Conducts quality control testing of utilities including high purity water systems (TOC, Conductivity, Endotoxin, and Bioburden) and compressed gas systems (hydrocarbon, moisture, bioburden, non-viable particulates, et cetera) 
• Conducts growth promotion testing and qualification testing to support environmental monitoring strategy
• Collects equipment swab samples in the manufacturing environment to support cleaning process verification testing
• Trends environmental monitoring data and writes environmental monitoring trend reports
• Writes microbiological testing protocols and conducts microbiological testing to support manufacturing qualification activities
• Authors Incident Reports, laboratory investigations, Change Controls, and CAPAs 
• May represent EM/Micro as an SME in support of cross-functional initiatives 
• Maintains laboratory cleanliness and organization through routine disinfection of laboratory surfaces and equipment, inventory management, and participation in 5S activities
• Coordinates with members of other departments to schedule sampling events and ensures timely communication of test results
• Logs samples and standards into the QC Laboratory
• Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies
• Identifies opportunities for improvement and takes initiative to lead improvement efforts
• Adjusts work schedule when necessary to meet testing needs
• Performs other related duties as assigned
• Responsibilities may increase in scope to align with company initiatives

Required Skills and Abilities

• Strong verbal and written communication skills 
• Strong analytical and problem-solving skills
• Demonstrated ability to collaborate and work in cross-functional teams 
• Excellent organizational skills and attention to detail 
• Strong time management skills with a proven ability to meet deadlines 
• Ability to prioritize tasks and to facilitate delegation of tasks when appropriate 
• Ability to function well in a high-paced and dynamic environment 
• Accepts feedback from a variety of sources and constructively manages conflict
• Proficient with Microsoft Office Suite or related software 

Education and Experience

• Bachelor’s degree in scientific discipline.  Degree in microbiology preferred.  
• Scientist I requires 1 year performing environmental monitoring testing and/or microbiological testing in a manufacturing environment.  
• Scientist II requires 2 years of GMP experience, 3-5 years preferred performing environmental monitoring testing and/or microbiological testing.  

Physical Requirements

• Prolonged periods of sitting or standing while monitoring equipment, analyzing data, or working on a computer
• Must be able to lift up to 25 pounds regularly
• Must be able to wear a Tyvek suit with PAPR for extended periods of time
• Exposure to constant low-level equipment noise, and occasional high-level alarms
• Work near heat generating equipment
• Move up and down ladders, kneel, squat, balance on one foot 
• Adheres to consistent and predictable in-person attendance